BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 1/10MM

    MDR report key: 9390198 · Received November 28, 2019

    Report

    Report Number
    3005180920-2019-01003
    Event Type
    Injury
    Date Received
    November 28, 2019
    Date of Event
    November 1, 2019
    Report Date
    November 28, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815904
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 NOVEMBER 2019: LOT 173724: 30 ITEMS MANUFACTURED AND RELEASED ON 25-JULY-17. EXPIRATION DATE: 2022-07-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 15 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 13 NOVEMBER 2019. GMK-PRIMARY 02.07.0681L REVISION FIXED TIBIAL TRAY CEMENTED SIZE 1 L (K123721) LOT. 186391 LOT 186391: 22 ITEMS MANUFACTURED AND RELEASED ON 07-AUG-18. EXPIRATION DATE: 2023-07-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 13 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-PRIMARY 02.07.F11030 PRIMARY EXTENSION STEM Ø11MM / L 30 MM LOT. 182980 LOT 182980: 150 ITEMS MANUFACTURED AND RELEASED ON 17-LULY-18. EXPIRATION DATE: 2023-06-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 144 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED 1 YEAR AFTER THE PRIMARY DUE TO PAIN CAUSED BY A SEVERE FLEXION CONTRACTION. THE CAUSE OF THE SEVERE FLEXION CONTRACTION IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY, INSERT, AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184951 GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 1/10MM TIBIAL INSERT PS FIXED JWH MEDACTA INTERNATIONAL SA 173724 07630030815904

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention